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OpenTrials
Completed

NCT Number: NCT00483808

Renal Denervation in Patients With Refractory Hypertension

To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Vincent's Hospital, Fitzroy, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >= 18 years of age.
  • a systolic blood pressure of 160 mmHg or greater.
  • receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening.
  • agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination.
  • competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion criteria

  • renal arterial abnormalities
  • end stage renal disease requiring dialysis or renal transplant
  • serum Cr > 3, or calculated GFR < 45 ml/min
  • has experienced MI, unstable angina pectoris, or CVA with 6 months
  • others

Treatment and study plan

Ardian Symplicity™ Catheter

Device

Renal denervation using the Symplicity Catheter

Primary outcomes

  1. To provide confirmation that renal denervation is safe and feasible.

    Time frame: 3 years

Secondary outcomes

  1. Evidence of renal denervation; indication of physiologic response; assessment of device performance.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jun 7, 2007
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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